Motpoly XR is an extended-release capsule that contains lacosamide which may be used to treat partial-onset seizures in adults and children weighing at least 110 pounds (50kg).

Motpoly XR was approved on May 4, 2023.

There are no contraindications to using Motpoly XR.

Do not stop using Motpoly XR suddenly or you may have increased seizures.

Some people have thoughts about suicide while using lacosamide. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Lacosamide may make you feel dizzy or faint. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.

Follow all the directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

The dosage of Motpoly XR depends on age, weight, and whether you are taking it with other seizure medications.

Motpoly XR may be taken with or without food. Swallow it whole with liquid. Do not open, chew, or crush the capsules. The extended-release capsules are available in capsules containing 100mg, 150mg, or 200mg of lacosamide.

Call your doctor if your seizures get worse or if you have them more often while using lacosamide.

Do not stop using lacosamide suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose. The dose of Motpoly XR should be tapered off over at least 1 week, longer if possible.

In case of emergency, wear or carry medical identification to let others know you use seizure medication.

Store at room temperature away from moisture and heat.

Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Adults (17 years and older)

• Monotherapy: 200mg once daily initially. Increase by 100mg once daily every week to a maintenance dose of 300mg to 400mg once daily.
• Adjunctive therapy: 100mg once daily initially. Increase by 100mg once daily every week to a maintenance dose of 200mg to 400mg once daily.

Dosages higher than 400mg/day are not any more effective and have been associated with higher rates of adverse effects. The maximum dosage in people with mild-to-moderate hepatic impairment is 300 mg/day.

Children weighing at least 110 pounds (50kg)

• Monotherapy: 100mg once daily initially. Increase by 100mg once daily every week to a maintenance dose of 300mg to 400mg once daily.
• Adjunctive therapy: 100mg once daily initially. Increase by 100mg once daily every week to a maintenance dose of 200mg to 400mg once daily.

Dosages higher than 400mg/day are not any more effective and have been associated with higher rates of adverse effects. The maximum dosage in people with mild-to-moderate hepatic impairment is 300 mg/day.

You should not use Motpoly XR if you are allergic to lacosamide or any of the inactive ingredients contained in the capsules.

Tell your doctor if you have ever had:

• heart problems
• kidney disease
• liver disease
• depression, a mood disorder, suicidal thoughts or actions
• drug or alcohol addiction or
• nerve problems caused by diabetes.

Some people have thoughts about suicide while using Motpoly XR. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Pregnancy

Do not start or stop using seizure medication such as Motpoly XR during pregnancy without your doctor's advice. It is best to talk to your doctor about your intention to get pregnant before you conceive, but if you inadvertently become pregnant tell your doctor right away. Having a seizure during pregnancy could harm both mother and baby.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of lacosamide on the baby.

Breastfeeding

It may not be safe to breastfeed while you are using lacosamide. Ask your doctor about any risks.

Children

Motpoly XR is not approved for use in children weighing less than 110 pounds (50kg).

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Motpoly XR may cause serious side effects.

Get emergency medical help if you have signs of a serious allergic reaction. Symptoms may include skin rash, difficulty breathing, fever, swollen glands, muscle aches, severe weakness, unusual bruising, yellowing of your skin or eyes, or swelling of the face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out
• a serious allergic reaction
• severe dizziness
• problems with balance or muscle movement
• chest pain, shortness of breath
• fast or pounding heartbeats
• very slow heartbeats or
• dark urine.

Common side effects of Motpoly XR may include:

• Dizziness
• double vision
• drowsiness
• headache
• nausea
• sleepiness

Avoid driving or hazardous activity until you know how lacosamide will affect you. Your reactions could be impaired.

This is not a complete list of side effects and others may occur. Call your doctor for more advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

Tell your doctor about all your other medicines, especially:

• heart or blood pressure medications, such as beta-blockers, calcium channel blockers, and sodium channel blockers because there is a risk of AV block or heart arrhythmias. An ECG may need to be obtained before initiation of Motpoly XR
• strong CYP3A4 (such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, grapefruit) or CYP2C9 inhibitors (such as clotrimazole, gemfibrozil, or miconazole) in patients with renal or hepatic impairment because this may increase the exposure to Motpoly XR. A dosage reduction may be necessary in these patients.
• concomitant administration with alcohol or other CNS depressant drugs (increased risk of CNS depression)

Motpoly XR may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

This list is not complete. Other drugs may affect lacosamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.